A Study to Assess the Bioequivalence of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Participants Compared With Clarityne Tablets

Healthy Clinical Trial

Official title:

A Single-Dose, Randomized, Open-Label, Two-Treatment, Four-Period, Crossover Study to Assess the Bioequivalence of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Subjects Compared With Clarityne Tablets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196531
• Other study ID #: CR108328
• Secondary ID: 1754415ALY1002
• Status: Completed
• Phase: Phase 1
• Start date: November 7, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: May 2020
• Source: Xian-Janssen Pharmaceutical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the bioequivalence of Xisimin (loratadine) compared with Clarityne in healthy participants receiving a single dose of 10 milligram (mg) under fasting condition as part of Cohort 1 and under fed condition as part of Cohort 2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• If a woman, must be surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (for example, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry, throughout the study, and for 1 month after the last dose of study drug

• If a woman, must have a negative serum pregnancy test at screening and a negative serum pregnancy test on Day -1 of each treatment period

• If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 2 months after receiving the last dose of study drug

• If a man who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (for example, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug. Must agree to continue using an appropriate method of birth control during the study and for 3 months after the last dose of study drug

• Body mass index (BMI, weight [kilogram]/height^2 [meter^2] {[kg]/height2 [m]2}) between 19.0 and 26.0 kilogram per meter square (kg/m2) (inclusive); body weight of male participants not less than 50 kilogram (kg) and body weight of female participants not less than 45 kg

Exclusion Criteria:

• History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), gastrointestinal disease, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results

• Clinically significant abnormal values for hematology, clinical chemistry, urinalysis, or 12-lead electrocardiogram (ECG) at screening as deemed appropriate by the investigator

• Clinically significant abnormal physical examination, or vital signs at screening or on Day -1 of each treatment period as deemed appropriate by the investigator

• Use of any prescription or Over-the-counter (OTC) drug (including vitamins and botanical supplements such as hypericum perforatum [St. John's wort]), except for oral contraceptives, within 14 days prior to scheduled administration of the first dose of study drug

• Positive test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C antibodies or syphilis serum test

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Loratadine (Xisimin [Test Treatment])
Participants will receive 10 mg loratadine as Xisimin (test treatment) as per the treatment sequence.
• Loratadine (Clarityne [Reference Treatment])
Participants will receive 10 mg loratadine as Clarityne (reference treatment) as per the treatment sequence.

Locations

Country	Name	City	State
China	Xiangya Hospital Central South University	ChangSha

Sponsors (1)

Lead Sponsor	Collaborator
Xian-Janssen Pharmaceutical Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of Loratadine	The Cmax is the maximum observed plasma concentration.	Cohort 1 and Cohort 2: Predose, 0.25 hour (h), 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h postdose
Primary	Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) for Loratadine	The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.	Cohort 1 and Cohort 2: Predose, 0.25 hour (h), 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h postdose
Primary	Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for Loratadine	The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.	Cohort 1 and Cohort 2: Predose, 0.25 hour (h), 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h postdose
Secondary	Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	From Screening to Day 5 of Period 4 (Approximately 33 days)